1. Overview of Amendments to Agenda the Food Sanitation Act 2

1. Overview of amendments to Agenda the Food Sanitation Act 2. Amended provisions 3. Details

1 １．Overview of amendments Agenda to the Food Sanitation Act ２．Amended provisions ３．Details

2 Food Sanitation Act: What are apparatus (utensils), containers and packaging?

Article 4 [Definition] (4) The term “apparatus" shall mean tableware, kitchen utensils, and other machines, implements, and other articles which are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives and which come into direct contact with food or additives. Example:

Tableware Kitchen utensils Others (5) The term "containers and packaging" shall mean articles which contain or wrap food or additives and are offered "as is" when delivering food or additives.

Example:

3 Countries Adopting the Positive List System for Food Utensils, Containers and Packaging

Positive List (PL) system Negative List system (Basically forbid usage and then list substances whose use (Basically allow usage and then list substances whose use is permitted) is limited)

Canada, Russia, Japan, Korea*, Thailand* and more The United States, EU, Israel, India, China, Indonesia, Vietnam, Australia, New Zealand, Saudi Arabia, Brazil, and *Korea and Thailand are considering to adopt the PL more system

Source: “The regulations of food utensils, containers and packaging in overseas– trends and applications, revised edition”, JOHOKIKO CO., LTD.

Major countries adopting the PL system

4 Outline of the Act Partially Amending the Food Sanitation Act etc. (Promulgated on June 13, 2018) Purpose of the amendment To respond to the change of environment on food in Japan and the globalization, and to ensure food safety, enhance measures for food poisoning on a wider scale, improve operators’ hygiene control, gather food-related health hazard information and take the countermeasures appropriately. In addition, organize sanitary regulations for utensils, containers and packaging (UCP) considering international consistency, and take measures such as updating a business approval and application system that reflect the reality of operators’ businesses, and establishing a reporting system for food recalls.

Outline of the amendment 1. Enhance measures for food poisoning on a wider scale The government and regional governments will collaborate with each other to prevent food poisoning and the spread on a wider scale. The Minister of Health, Labour and Welfare will establish a council of a wide-scale partnership with associates and respond to emergencies through the council. 2. Requirement of food hygiene control based on HACCP system* In principle, all food operators will be required to conduct hygiene control that complies with HACCP as well as general hygiene control. However, hygiene control by operators with certain scale and specific business type should be conducted according to the character of the food they handle. * HACCP is a hygiene control approach with which operators understand risk factors including food poisoning contamination, manage key processes at all stage from procurement of raw ingredients to product shipment in order to remove or reduce risk factor, and ensure safety. It is becoming mandatory in developed countries. 3. Gathering health hazard information on the foods containing ingredients that require special caution To prevent health hazards in advance, urge operators to submit health hazard information to the government about foods containing ingredients that require special caution. 4. Improvement of sanitary regulations for UCP considering international consistency Introduce the Positive List system to food UCP, which only substances assured its safety and considered safe are permitted to be used for UCP. 5. Revision of licensing system and establishment of notification system for food business Update the current business categories reflecting their business more accurately and establish a notification system for operators who does not belong to the current business categories (34 categories specified by the cabinet order). 6. Establishing a reporting system for food recalls Establish a reporting framework for operators to report to their local government when they voluntarily recall their products. 7. Others (for example, a requirement of a hygiene certificate to import dairy products or seafood and establishment of regulations on local governments’ works for food export)

Effective date of the amended Act The day specified by the cabinet order, within two years (1 year for above 1. and 3 years for 5. and 6.) from the date of promulgation of the amended Act 5 Improvement of Sanitary Regulations for Utensils, Containers and Packaging Considering International Consistency

 To ensure international consistency on safety and regulations of utensils, containers and packaging (UCP), only substances whose safety has been ensured are permitted to be used for UCP, and the UCP made of raw materials without specifications and standards are prohibited to be sold etc. Current system New system (Positive List system)

 All substances are basically permitted to be used and  All substances are basically prohibited to be substances whose use should be limited are specified. used, and only substances assured its safety are The government cannot regulate immediately the permitted to be used for UCP. substances whose use is prohibited in other countries * Subject to the system: synthetic resin unless the specifications and standards are established.

Overview of the Risk management under the Positive List system by the Government ・Inspection (Have UCP business operators submit notification of business and instruct them.) Positive List system ・Import monitoring

Management according to the Good Manufacturing Practice (GMP) ・Check raw materials ・Save manufacturing records, etc. ・Provide product information to confirm conformance to the standards and the specification

* To the manufacturers not covered by the Positive List system, general hygienic management is applied.

(UCP user) (UCP

Consumer

UCP Vender UCP

Manufacture

Raw material Raw

UCP Manufacture UCP Food manufacture Food

Provide appropriate information Provide appropriate information to to confirm conformance to the confirm conformance to the Positive Positive List upon request. List. 6 １．Overview of amendments to Agenda the Food Sanitation Act ２．Amended provisions ３．Details

7 Food Sanitation Act: Key Relevant Articles Concerning Utensils and Containers and Packaging Chapter I General Provisions → Article 1 [Purpose], Article 3 [Responsibility of food business operators], Article 4 [Definitions] Chapter III Apparatus (Utensils) and Containers and Packaging → Article 15 [Principles of handling utensils and containers and packaging used in business] Article 16 [Prohibition on sale etc. of toxic or harmful utensils or containers and packaging] Article 17 [Prohibition on sale etc. of specific utensils etc.] Article 18 [Establishment of specifications and standards for utensils or containers and packaging] Chapter VII Inspections → Article 26 [Inspection order], Article 27 [Notification concerning imports], Article 28 [On-site inspection and removal] Chapter IX Business → Article 55 [Rescission etc. of approval] Chapter X Miscellaneous Provisions → Article 58 [Notification concerning poisoning] Chapter XI Penal Provisions → Articles 71, 72 and 73 [Penal provisions]

* This is provisional translation. Please refer to the original amended Act written in Japanese. 8 Amended Food Sanitation Act (Excerpt of provisions related to utensils, containers and packaging) Article 18 (Paragraph (3) was newly added.) (1) From the viewpoint of public health, the Minister of Health, Labour and Welfare may establish standards for the utensils or containers and packaging, or the raw materials thereof to serve the purpose of marketing or to be used in business, or establish the criteria for the production methods thereof, by hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council. (2) (Omitted) Targeted materials: synthetic resin (3) Raw materials for materials specified by the Order for Enforcement of the → Food Sanitation Act (the Cabinet Order) by taking into consideration the impact Prescribed in the Order of eluting or seeping out ingredients into food on public health, which contain for Enforcement of the substances (excluding substances generated by chemical change of such Food Sanitation Act substances) for which the standards prescribed in paragraph 1 have not been established in terms of the quantity allowed to be contained in utensils or The Positive List containers and packaging manufactured using such raw materials or the → quantity allowed to be eluted or seeped out into food from utensils or Prescribed in the Public containers and packaging manufactured using such raw materials, shall not be Notice of the MHLW used in any utensils or containers and packaging. However, this shall not apply when utensils or containers and packaging have been processed so that such substances are not be eluted or seeped out into food in a quantity exceeding the The quantity that is quantity that the Minister of Health, Labour and Welfare specifies as being unlikely harm to unlikely harm to human health by hearing the opinions of the Pharmaceutical → human health Affairs and Food Sanitation Council (excluding cases where such substances are Prescribed in the Public used in part of utensils or containers and packaging that will directly contact Notice of the MHLW food). * This is provisional translation. Please refer to the original amended Act written in Japanese. 9 Amended Food Sanitation Act (Excerpt of provisions related to utensils, containers and packaging) Article 52 (Newly added) (1) The Minister of Health, Labour and Welfare shall establish the criteria for • General sanitary the matters listed below by an Ordinance of the Ministry of Health, Labour and Welfare concerning sanitary management of business facilities where management utensils or containers and packaging are manufactured and other measures • Management of necessary for public health (hereinafter referred to as the “Necessary Public manufacture according Health Measures” in this Article): to the Good → (i) maintaining the cleanliness of the interior and exterior of business Manufacturing Practice facilities and other general matters concerning sanitary management; and Prescribed in the (ii) matters concerning efforts to properly manage the manufacture which Ordinance for Enforcement are necessary to prevent the food sanitation hazards. of the Food Sanitation Act (2) A business person who manufactures utensils or containers and packaging shall take necessary measures for public health in accordance with the criteria established pursuant to the provisions of the preceding paragraph (limited to the matters listed in the preceding paragraph, item 1 if a business person produces utensils or containers and packaging using only raw materials for the materials other than those specified by the Cabinet Order as prescribed in Article 18, paragraph 3.)

(3) The prefectural governor etc. may establish the necessary provisions concerning the necessary measures for public health unless they are consistent with the criteria established pursuant to the provisions of paragraph 1.

* This is provisional translation. Please refer to the original amended Act written in Japanese. 10 Amended Food Sanitation Act (Excerpt of provisions related to utensils, containers and packaging) Article 53 (Newly added) (1) A person who sells or manufactures or imports for the purpose of marketing any utensils or containers and packaging in which the materials specified by the Cabinet Order as prescribed in Article 18, paragraph 3 are used shall explain to a Obligation to provide party to whom he/she sells the utensils or containers and packaging he/she necessary information handles that the utensils or containers and packing so handled by him/her fall between manufacturer, under either of the following items, pursuant to an Ordinance of the Ministry of vender and importer Health, Labour and Welfare: → (i) the utensils or containers and packaging only use raw materials for the materials specified by the Cabinet Order as prescribed in Article 18, Prescribed in the paragraph 3 that conform to the standards established pursuant to the Ordinance for provisions of the same Article, paragraph 1; or Enforcement of the (ii) the utensils or containers and packaging have been processed in the manner Food Sanitation Act prescribed in the proviso of Article 18, paragraph 3.

(2) A person who sells or manufactures or imports for the purpose of marketing the raw materials for utensils or containers and packaging which fall under the Endeavor to provide materials specified by the Cabinet Order as prescribed in Article 18, paragraph 3, necessary information by if requested by a person who manufactures any utensils or containers and business operators packaging using such raw materials to confirm that such raw materials conform to handling raw materials the standards established pursuant to the provisions of the same Article, paragraph 1, shall endeavor to provide necessary explanation pursuant to an → Ordinance of the Ministry of Health, Labour and Welfare. Prescribed in the Ordinance for Enforcement of the

* This is provisional translation. Please refer to the original amended Act written in Japanese. Food Sanitation Act 11 Amended Food Sanitation Act (Excerpt of provisions related to utensils, containers and packaging) Article 57 (Newly added) (1) A person who intends to conduct a business (excluding businesses Notification system of prescribed in Article 54, businesses which have a minor impact on manufacturing for public health and are specified by the Cabinet Order and poultry domestic manufacturers slaughtering businesses) shall notify the prefectural governor, in → Prescribed in the advance, of the name and location of the business and other Ordinance of matters specified by an Ordinance of the Ministry of Health, Labour and Welfare pursuant to an Ordinance of the Ministry of Health, Enforcement of the Labour and Welfare. Food Sanitation Act (2) （Omitted) Effective Date Article 1 of the Supplementary Provisions This Act comes into effect on the day specified by the Cabinet Order within a period not exceeding two years from the date of promulgation. (Omitted)

Transitional Measures Article 4 of the Supplementary Provisions The provisions of Article 18, paragraph 3 and Article 50-4 (omitted) of the new Food Sanitation Act shall not apply to utensils (omitted) and containers and packaging (omitted) sold, produced or imported for the purpose of marketing, or used in business (omitted) at the time of the enforcement of this Act. * This is provisional translation. Please refer to the original amended Act written in Japanese. 12 Supplementary Resolutions to the Bill Partially Amending the Food Sanitation Act etc.

1. to 3. (Omitted)

4. When introducing the Positive List system for food utensils and containers and packaging, take all possible measures to ensure the smooth enforcement of the Act such as establishing specifications and standards in a systematic manner based on the assessment of the effect of food on health. Also, consider to develop the positive lists for materials other than synthetic resin considering the risk level and international trends.

5. to 8. (Omitted)

* This is provisional translation. Please refer to the original amended Act written in Japanese.

13 １．Overview of amendments to Agenda the Food Sanitation Act ２．Amended provisions ３．Details

14 Materials Specified by Cabinet Order as Applicable to the Positive List (PL)

 Materials including synthetic resins, paper and rubber products are used in food utensils, containers and packaging (UCP), and specifications by material are specified in the Specifications and Standards for Food, Food Additives, etc. (Ministry of Health and Welfare Notification no.370, 1959).

Article 18, paragraph 3 of the amended Food Sanitation Act prescribes that the raw materials for materials applicable for the PL system shall be those which standards have been prescribed in paragraph 1, and that the applicable materials shall be specified by the Order for Enforcement of the Food Sanitation Act (the Cabinet Order).

 Based on the following reasons, synthetic resins shall first be applicable for the PL system:

(1) The material is used extensively in various utensils, containers and packaging and its impact toward public sanitation must be taken into consideration; (2) The material is included in the PL systems of other countries such as in Europe and the United States; (3) The material has been independently managed by a trade association 15 Scope of the Positive List for “Synthetic Resins”

Classification of Synthetic Resins (Overview)

Thermoplastic resins Thermosetting resins

Plastic Thermoplastics Thermosetting plastics e.g., polyethene, polystyrene e.g., melamine resin, phenol resin

Thermoplastic elastomer Rubber (thermosetting elastomer) Elastomer e.g., polystyrene elastomer, styrene-block e.g., butadiene rubber, nitrile rubber copolymer

Supplement Without a cross-linked structure With a cross-linked structure

Applicable criteria to the Positive List (draft) • “Rubber” will be differentiated from synthetic resins as “a non-thermoplastic, high-polymer elastic body with a cross-linked structure.” • The part excluding “rubber” will be handled as synthetic resin and subject to the positive list system.

16 Comparison of the Regulations in Japan, Europe, and the United States (After the amendment)

Synthetic resins Metals, Paper, Thermosetting Thermoplastic resins resins glass, (for general purpose: rubber (for general purpose: about 30 kinds) about 10 kinds) etc.

PL System in the U.S. Regulation PL System in the EU by country PL System in Japan

 The United States: A Positive List system for synthetic resins, paper, and rubber products was established in 1958, which confines the chemical substances that can be used with those listed in the Code of Federal Regulations (CFR). For synthetic resins, the CFR prescribes the monomers and additives that can be used and their content for each type of polymer. Also, the Food Contact Notification (FCN) system, a premarket notification for food contact substances, was established in 2000, which limits their use to the notifier for each product, in order to accelerate the process of inclusion in the Positive List. Manufacturing products under the Good Manufacturing Practice (GMP) is mandated for manufacturers including raw material manufacturers. However, there is no particular regulation on information sharing among business operators, which is left to self-management and self- declaration.  Europe (EU): A PL system for synthetic resins was established in 2010, which limits the migration levels, use conditions, and other necessary matters for each monomer and additive. Additionally, the system also regulates the total migration level of ingredients contained in the products and their materials. Manufacturing products under the Good Manufacturing Practice (GMP) are mandated for manufacturers including raw material manufacturers. The issuance of a “declaration of compliance,” which certifies the compliance of raw materials and products with the Positive List, is mandated to share information among business operators.  Japan: A PL system for synthetic resins will be introduced first. Manufacturing control under the GMP and information sharing with purchasers are mandated for manufacturers of utensils, containers, and packaging (UCP). Additionally, UCP raw material manufacturers should provide information upon request. 17 Synthetic resins etc. used in paper

Summary

Synthetic resins etc. used in paper which have a synthetic resin layer on the food-contact surface are subject to the positive list system for synthetic resins.

Scope of the positive list for synthetic resins

In scope Film lamination Synthetic resin coating Food side Food side Synthetic resin layer Synthetic resin layer

Paper Paper

External side External side A synthetic resin film is laminated to Synthetic resin coating is formed the surface of paper on the surface of paper Out of scope ⇒ To be controlled by the positive list for paper in the future

Pigment coating Penetrated additive Internal additive Polymer Food side Polymer (e.g., size press) Polymer Pigment Food side Food side layer Paper Paper Paper External side External side External side Polymers function as a binder of Polymers are penetrated into pre- Polymers are added to pulp pigments such as kaolin and calcium dried or dried paper as a roll slurry carbonate 18 Handling of Synthetic Resin Layer (e.g., ink, adhesives)

Summary If substances used in synthetic resin (including ink and adhesives) of the middle layer (non-food contact layer) are controlled not to migrate into foods exceeding a certain level, they shall be subject to the proviso in Article 18(3) : if a substance does not listed in the Positive List but the migration into food does not exceed a certain level, the substance can be used for utensils, containers and packaging. Scope of the positive list for synthetic resins In Scope

Food side Food side Synthetic resin layer Synthetic resin coating layer

External side External side e.g., film lamination e.g., lacquer paint, hot melt

Application of Proviso in Article 18(3) of the Food Sanitation Act Food side Food side

Synthetic resin layer Synthetic resin layer (Non-food contact layer) (Non-food contact layer) e.g., ink, adhesives e.g., ink, adhesives External side External side Control manufacturing to prevent the substance in the layer from migrating into food exceeding a certain level before the If migration into food exceeds a certain level , expiration/use-by date. In the future, conditions to ensure there is no individual substances are required to be included in the Positive List. migration exceeding a certain level will be considered. 19 About “Quantity Being Unlikely to Harm” in the Proviso in Article 18 (3)

According to Article 18 (3) of the amended Food Sanitation Act, although the raw materials for materials (synthetic resins) specified by the Cabinet Order must be substances in the Positive List, substances not listed in the list may also be used if not used in areas that come in contact with food and do not transfer to food in quantities that exceed amounts deemed as unlikely to harm human health.

In that case, the quantity deemed as unlikely to harm human health shall be specified according to the concentration within food-simulating solvents rather than the dietary concentration of the substance eluted or seeped out from utensils, containers and packaging (*) when considering the effectiveness of risk management. * Calculations of dietary concentrations require conversions that apply factors etc. to values obtained from dissolution tests that use food-simulating solvents.

[Excerpt from Reference Material 2 of utensils, containers and packaging (UCP) section (July 8, 2019)]  The quantity that the Minister of Health, Labour and Welfare specifies as being unlikely to harm human health pursuant to the proviso in Article 18 (3) of the amended Food Sanitation Act shall be 0.01mg/kg for food.  The quantity migrated into food is calculated by multiplying the concentration in the food- simulating solvent by the factor (weight of food that contacts with UCP/quantity of food- simulating solvent) . This factor may be approximated to 1. Therefore, the migration (0.01mg/kg) into food may be considered as 0.01mg/L for the concentration in the food- simulating solvent. 20 Specifications and Standards in the PL System

The substances to be managed in the PL system shall be prescribed in the Public Notice.

 The substances to be managed under the PL system shall be the following: • Main components of synthetic resin (base polymers) • Substances that are expected to remain in final products to physically or chemically change the properties of synthetic resin

 Catalysts and polymerization aids are used for polymerization of monomers. They do not become part of base polymers and are not expected to remain in final products. Therefore, they shall be managed according to the conventional risk management methods not according to the PL.

 Coloring materials shall be comprehensively specified as “(1) Colorants listed in Appended Table 1 of the Order for Enforcement of the Food Sanitation Act (Ordinance No. 23 of the Ministry of Health and Welfare, 1948) and (2) Colorants processed so they will not be eluted or seeped out into food” based on the current management method according to the Notification No. 370 of 1959 and consistency with international standards while maintaining the same approach as the current management method pertaining to colorants specified in the Notification.

 The migration and other necessary restrictions for additives etc. shall be stipulated as needed, assuming additives etc. will be managed according to the amount added (content) to each substance.

 Synthetic resins shall be classified into some groups according to their characteristics and current use status; and the use level of additives etc. shall be specified and managed by the group. 21 Materials Consist of Utensils, Containers and Packaging

Utensils, Containers or Materials consist of UCP (Raw materials) Packaging (Final Product) Base Polymers

Additives

22 Substances Controlled by the Positive List

＊＊＊ Additive/ Additive/ Additive/ Agent a Agent b Agent c

＊ Processing Final product Base Interim Monomer raw (Utensils, polymer product containers, and material (e.g., film, sheet) packaging)

Reaction Additive/ control agent (e.g., catalyst) Agent d

Impurities/unexpected products

*To be controlled under the Positive List system

Scope of substances to be included in the Positive List • Substances which are expected to remain in final products are managed in the Positive List (*). • Substances which are not expected to remain in final products are managed by the existing risk management method. * Coloring is a substance which is expected to remain in final products and thus is subject to the Positive List system for synthetic resins. Based on the concept same as the current risk management method (chemical artificial coloring other than designated food additives shall be processed not to be mixed into food by migrating or leaching), it will be comprehensively included in the Positive List and managed. 23 Ｃｌａｓｓｉｆｙｉｎｇ Method for the Positive List (Grouping Method of Synthetic Resin)

Summary Classify resins into several groups based on base polymers, their property (physiochemical property), and current use status; and determine use level of additives etc. according to the group. Objectives • Assure wide range of combination of resins and additives etc. while managing migration levels of additives into food. • Protect intellectual property by not specifying the combinations of resins and additives. • Simplify the Positive List.

Idea of base polymer grouping

Consumption Resin property factor Oil resistance Water resistance

Very strong Very strong

Small Weak Strong

Strong Weak

Large - -

Note: The number of groups may be changed based on property and use status. 24 Synthetic Resin Grouping Method

Summary Classify resins into several categories based on base polymers, their property (physiochemical property) and current use status; and determine use level of additives etc. according to the category.

Synthetic resin with consumption Yes factor of ≥ 0.1 Assumed resin Consumption factor Yes No Polymers with ≥50 wt% ethylene Group 5 PE 0.25 No Yes Polymers with ≥50 wt% propylene Group 6 PP 0.16 No Polymers with ≥50 mol% of the total of Yes PET terephthalic acid and ethylene glycol Group 7 0.22 Total percentage of contents derived from chloroethylene or vinylidene Yes 0.05 chloride in polymers is ≥50 wt% Group 4 PVC, PVDC PVC:0.02 No PVDC:<0.001 • Heat-resistance polymers with glass-transition temperature or ball pressure temperature, etc. of ≥150℃ (JIS K7121, JIS C60695-10-2, Engineering plastic, Yes Group 1 0.05 etc.) or, Thermosetting resin, etc. • Heat-resistance polymers that have a cross-linked structure and All <0.001 melting point of ≥150 ℃ (JIS K7121) No 0.07 Polymers with the water absorption rate of ≤0.1% Yes Group 2 Olefin etc. PS:0.06 (JIS K7209) Other <0.001 No Polymers with the water absorption rate of >0.1% Yes Group 3 Polyester, polyamide, etc. 0.05 (JIS K7209) Other <0.001 *Consumption factor is obtained by estimating percentage of the diet that contacts with specific materials used for UCP in total. *Groups 1 to 3 can be applied to resins in Groups 5-7 if the consumption factor is very small due to their specific use etc. *Although the principle of grouping criteria is above chart, substances may be comprehensively classified based on heat-resistance 25 temperature, chemical resistance, etc. Reference: Calculation of consumption factors etc.

 Consumption factors and food-type factors are used when calculating the dietary concentration of a substance under the PL system when confirming its safety. (Described in the Guideline for Assessment of the Effect of Food on Human Health Regarding Food Utensils, Containers and Packaging by the Food Safety Committee of Japan.)

 A survey project by the MHLW (2010) investigated material types and their weight of containers and packaging used for food in the market by food item. Consumption factors were derived from the percentage of materials by the food item and that of food overall. Food-type factors were derived from the quantity used for container and packaging by material for each food-type (aqueous, acid, oil, alcoholic, dairy, dry foods, etc.). Consumption factors etc. for synthetic resin below were set by classifying these factors by material into groups of synthetic resin according to characteristics of polymers.

Consumption factor: Factor obtained by estimating percentage of the diet that contacts with specific materials used for UCP in total. Food-type factor: Factor obtained by estimating percentage of UCP used for foods of a specific food type by material. *UCP: utensils, containers and packaging

Synthetic resin Consumption Food-type factor (DF) group (type) * factor Normal foods Acidic food Alcoholic Dairy etc. Oils and fats (CF) Dry foods beverage

D1 D1sub D2 D3 D4 D5 Resin Group 1 0.05 The food group factor for the food group with the highest migration quantity shall be 0.96, and the factor of other food groups being 0.01. Resin Group 2 0.07 0.38 0.02 0.27 0.01 0.11 0.23 (PS etc.) When PS is not used for a migrating test: Use 0.96 for DF of the food group with the highest migration quantity (Q), and use 0.01 for DF of other food groups. Resin Group 3 0.05 0.92 0.01 0.01 0.01 0.01 0.05 (PA etc.) When PA is not used for a migrating test: Use 0.96 for DF of the food group with the highest migration quantity (Q), and use 0.01 for DF of other food groups. Resin Group 4 0.05 0.93 0.01 0.01 0.01 0.01 0.04 (PVC, PVDC) Resin Group 5 (PE) 0.25 0.88 0.03 0.04 0.01 0.02 0.05 Resin Group 6 (PP) 0.16 0.80 0.05 0.05 0.01 0.02 0.12 Resin Group 7 0.22 0.86 0.01 0.09 0.01 0.01 0.03 (PET)

*Synthetic resin groups are classified based on the properties of base polymers (physicochemical properties) and current use status. PS: polystyrene, PA: polyamide, PVC: polyvinyl chloride, PVDC: polyvinylidene chloride, PE: polyethylene, PP: polypropylene, PET: polyethylene terephthalate 26 Specifications of Base Polymers

Summary  When initial monomers and manufacturing method differ, the polymers shall generally be treated as different base polymers even if the synthesized base polymer structures are the same.  Base polymers with different source-based names shall be listed separately in the Positive List even if they have the same structure-based name. Example: Polycarbonates

No Polymers English name CAS No.

2, 2-bis (4-hydroxyphenyl) propane, carbonyl chloride Carbonic dichloride, polymer with 4,4'-(1- 25971-63-5 1 copolymer methylethylidene)bis[phenol] 24936-68-3

2, 2-bis (4-hydroxyphenyl) propane, diphenyl carbonate Carbonic acid, diphenyl ester, polymer with 25929-04-8 2 copolymer 4,4'-(1-methylethylidene)bis[phenol] 24936-68-3

 Source-based name  Structure-based name (1) 2, 2-bis (4-hydroxyphenyl) propane, carbonyl chloride copolymer  Poly [oxycarbonyloxy-1,4-phenylene CAS No. 25971-63-5 (dimethylmethylene) -1,4-phenylene CAS No. 24936-68-3 Interfacial polymerization

Carbonyl chloride

(2) 2, 2-bis (4-hydroxyphenyl) propane, diphenyl carbonate copolymer CAS No. 25929-04-8 Source-based name Transesterification Name based on the ingredient monomer. Structure-based name Diphenyl carbonate Name based on the chemical structure of the polymer’s repeating unit. 27 Rules for the Positive List (PL) on Base Polymers and Minor Monomers (98% Rule)

Summary  Information of minor monomers constitute polymers directly correlates with trade secrets of companies. Therefore, consideration is required for the way of listing while ensuring the safety of public health.  More than 98 wt% of the components of a base polymer shall be constituted with polymers listed in the PL.  Substances of which the remaining components of the polymer consists (minor monomers) shall be listed in and managed by the list of minor monomers compiled separately from the list of polymers by resin.

98% rule (draft)

0 wt% 98 wt% 100 wt%

Conditions

Polymer ABC (1) Polymer AB is included in the PL as a base polymer (2) A and B in Polymer ABC exceed 98% weight as the polymer’s structural components (3) Monomer C is included in the PL as a minor monomer Polymer AB (Listed on the PL) The polymer ABC may be treated as Monomer A Polymer AB only if it satisfies all three Monomer B conditions above. Monomer C (Listed on the PL (Minor Monomer List))

* As needed, minor monomers are restricted to be used in some polymers and managed by the current risk management method (negative list system). 28 Rules for Substances with Polymer Structures

 Substances with polymer structures are sometimes used as additives to manufacture synthetic resins. These substances shall be included in the list as additives.

 Specifically, the following substances with polymer structures shall be listed as additives: (1) Substances of materials classified apart from synthetic resin (rubber, cellulose, etc.) (2) Substances with polymer structures such as the following that normally will not become UCP when used alone • Substances with low viscosity and that become liquid at room temperature (polyethylene glycol, ester, etc.) • Substances with under 1,000 in molecular weight (excluding when they can become UCP) • Other substances that are appropriate to manage as additives based on the purpose of use and quantities

 In addition, if synthetic resins are mixed together, the synthetic resin with polymer structure shall be listed and managed as a base polymer rather than an additive for the other synthetic resin.

Polymer A Polymer B

Polymer additive B Base polymer A 29 Positive List Format

(1) Base polymers More than 98 wt% of the components of a base polymer shall be polymers listed below. ● AA resin Food types Maximum Polymers temperature Oily Milk and No CAS No Alcoholic I. ≤70℃ Group Remarks Acidic and milk Others beverage II. ≤100℃ Japanese name English name fatty product III. ≥101℃

1 Homopolymer of AA AA polymer 0000-00-0 ○ ○ ○ ○ ○ Ⅲ １

2 Copolymer of AA and BB AA polymer with BB 1111-11-1 ○ ーー ○ ○ Ⅲ ２ ● BB resin Food typesSet “group” forMaximum each Polymers polymer temperatur Oily Milk and e No CAS No Alcoholic Group Remarks Acidic and milk Others I. ≤70℃ beverage Japanese name English name fatty product II. ≤100℃ III. ≥101℃ 1 Homopolymer of BB BB polymer 2222-22-2 ○ ○ ○ ○ ○ Ⅲ 3

2 Copolymer of BB and ZZ BB polymer with ZZ 3333-33-3 ー ○ ○ ○ ○ Ⅱ 3 ● Minor monomers can be used for polymerization of base polymers ※ Minor monomers are restricted to be used in Minor monomers some polymers and managed by the current No CAS No Remarks risk management method (negative list system) Japanese name English name as needed. Restrictions on use level of 1 XX XX 5555-55-5 additives and other agents 2 YY YY 6666-66-6 will be set by polymer group. (2) Additives, coating agents, etc. Substance name Maximum use level by group (wt%) No CAS No The useRemarkslevel of the Japanese name English name 1 2 3 4 5 6 7 additives etc. is described in percentage for the 1 aaa aaa 9999-99-9 1.0 1.0 - - 1.5 1.0 - whole synthetic resin 2 bbb bbb 8888-88-8 - 5.0 2.0 2.0 2.0 2.0 2.0 including the additives etc. 30 Single Resin and Mixed Resin

Single Resin Mixed Resin

Single copolymer A

Polymer blend

Alternating copolymer AB

Random copolymer AB

Two or more polymers are blended Block copolymer AB

Graft copolymer AB

No need to be listed as mixed resin in the Positive List

※ Each Polymer shall be listed in the Positive List. ※ Need to be listed as base polymer in the If a resin has a chemical reaction, the resin is not regarded as mixed resin. Positive List 31 Mixture of Synthetic Resins (Mixture Rule 1)

Summary  When multiple resins in the PL are mixed, the mixed resin shall be treated as applicable to the PL.  In this case, restrictions for each resin (applicable food type, applicable temperatures, additive quantities, etc.) shall also apply for the mixed resin. Mixed resin AB Conditions of synthetic resins for mixed resin and the additives Synthetic resin A Base polymer Additive Additive

Needs to be listed in the PL Synthetic resin A Needs to be listed Needs to be listed (Treated as food contact layer) in the PL with use in the PL with use Mix Synthetic limit of the group limit of the group A and B resin B for synthetic resin for synthetic resin Additives Needs to be listed in the PL Synthetic resin B (Treated as food contact layer) A or B A or B Maximum use levels of additives Ex. Additives x and z may be used for synthetic resin A. Synthetic resin A Synthetic resin B Additives y and z may be used for synthetic resin B. → Additives x, y and z may all be used for mixed resin AB. Additive x Additive z Additive y However, the maximum use level shall be according to the standards of the resin before being mixed.

Synthetic resin Synthetic resin Mixed resin AB Remarks A B

Resin weight 2 kg 1 kg 3 kg

Not 300g (10 wt% Maximum use Maximumuse level 200g 0g 200g Additive x of the total weight, (Maximum: 10 wt%) (Not listed in PL) (Maximum: 6.7 wt%) 3kg)

0g 50g 50g Not 150g (5 wt% Additive y of the total weight, (Not listed in PL) (Maximum: 5 wt%) (Maximum: 1.7 wt%) 3kg) Mix A and B Additive z 400g 100g 500g (Maximum: 20 wt%) (Maximum: 10 wt%) (Maximum: 17 wt%)

• The maximum temperature shall be severer between the resins A and B. Food types of the mixed resin shall be the types of both resins. 32 Mixture of Synthetic Resins (Mixture rule 2)

Summary

 When multiple resins listed in the PL are mixed, the restrictions for the each resin before mixture (applicable food types, applicable maximum temperature, etc.) shall apply to the mixed resin. In general, the severest conditions of the resins shall apply to the mixed resin.  In some case, more lenient restrictions may apply when a polymer with lenient restrictions is mixed with small amounts of a polymer with severe restrictions. Example: If a mixed resin consists of a polymer with maximum temperature I and small amounts of a polymer with maximum temperature III, the temperature III is applied to the maximum temperature of the mixed resin.  Such mixed resins shall be managed with descriptions in the Remarks columns, which clarify exceptions for the mixture rule.

Example

Food types Max. temperature Polymers I: 70ºC or lower No CAS No Oily and Milk, dairy Alcoholic II: 100ºC or lower Group Remarks Acidic Others Japanese fatty product beverage III: a temperature English name name exceeding 100ºC If mixed with resin Copolymer of , restrictions for 1 AA polymer with BB 1111-11-1  - -   II 2 AA and BB the resin may be applied.

*The migration and the safety need to be confirmed accordingly to describe the applicable restrictions of the resin being mixed into.

33 Special Case 1: Rules for Substances Used Only in Non-contact Food Layers

Summary  When substances used only in non-contact food layers migrate to food in amounts that exceed certain levels, the said substance needs to be listed in the PL (the proviso in Article 18 (3) does not apply).  In such case, the use limit of the additives is described in the group that the base polymer used in the non- contact food layer belongs. Example

(1) When Additive A is used only in non-contact food layers Additive A Food side

 Additive A shall be listed under the group in which Synthetic resin Y falls under (Group 2). Synthetic resin X *Not Group 1 in which Synthetic resin X used in contact food layers falls under. (Group 1)  Synthetic resin Y’s resin group needs to be confirmed to set the use limit of Additive A.  Description of limitation in the Remarks column is mandatory. Synthetic resin Y  If the monomer etc. derived from the base polymer of Synthetic resin Y does not migrate into (Group2) food exceeding a certain level, Synthetic resin Y does not need to be listed in the PL. External side Needs to be classified into the group of the non-contact food layer, Synthetic resin Y (Group 2) . Description in the public notice (draft) Use restriction by group No Substance name Remarks 1 2 3 4 5 6 7 1 Additive A - 2.0 - - - - - Used only in non-contact food layers

(2) When base polymers of a synthetic resin are used only in non-contact food layers (When the monomer etc. migrates into the food exceeding a certain level)  The Base polymers shall be listed in the PL with limitation in the Remarks column (Example: “Used only in non-contact food layers”).

Description in the public notice (draft) Food types Max. No Polymers Oily and Milk, dairy Alcoholic Group Remarks Acidic Others temperature fatty product beverage Used only in non-contact food 1 Polymer Z - - - - - III 3 layers 34 Special Case 2: Rules for Restrictions of Base Polymers Used in Non-contact Food Layers

Summary  When a base polymer is used in non-contact food layer of utensils, containers and packaging with multiple layers, the restrictions on food types of the base polymer shall not apply. However, the maximum temperature of the base polymer shall apply in principle.

Example Food types Max. temperature I: 70ºC or lower No Oily and Milk, dairy Alcoholic II: 100ºC or lower Group Remarks Acidic Others Polymers fatty product beverage III: a temperature exceeding 100ºC

1 Polymer X -     III Max. 1temperature 100ºC or lower (II) even for non-contact layer 2 Polymer Y      II 2

May be used for acidic food if If used in non-contact used in non-contact layer food later, the max. 3 II 2 Polymer Z temperature falls under Ⅲ. General rules (apply restrictions of respective polymers) If a polymer has remarks. Food side Food side Food side

Synthetic Synthetic Synthetic resin Y resin X resin X

Synthetic Synthetic Synthetic resin X resin Y resin Z External side External External side Acidic food  Acidic food × side Acidic food × Max. temperature II Max. temperature II Max. temperature III 35 Special Case 3: Functional Ingredients (Active/Intelligent Ingredients)

Summary  In the EU, ingredients that extend food shelf-life or conditions through releasing or absorbing specific chemical substances are defined as “active ingredients” and those that monitor packaged foods and surrounding environments are defined as “intelligent ingredients” and systemize regulations on these food contact ingredients.  Chemical substances contained in UCP are managed as substances applicable for PL as raw ingredients of UCP, regardless of their effects on food.  Chemical substances released from UCP expected to have effects on food are applicable for regulations as food additives, regardless of their migration amounts (they are raw ingredients of UCP as the status of part of a base material). *UCP: utensils, containers and packaging

Classification Regulatory framework Example

Absorbing

- Oxygen scavenger Managed as substances applicable for PL for UCP - Drip absorber

Releasing

Active ingredients Managed as substance applicable for PL in UCP and as food Released substance additive (Because the substance is a raw ingredient for the UCP material before being released from UCPs, and have effects on the condition of Freshness-keeping agent that food after being released from UCPs) releases mustard extract (food additive)

Base material Managed as substances applicable for PL for UCP

Immobilized Immobilized substance

Anti-microbial product that contains Managed as substances applicable for PL for UCP silver zeolite Base material

Intelligent ingredients Managed as substances applicable for PL for UCP* *Based on the same concept as the current risk management method (chemical artificial coloring other than designated food additives shall be processed not to Temperature indicator be mixed into food by migrating or leaching), colorants will be comprehensively included in the Positive List. 36 Special Case 4: Rules for Active Ingredients

 When use a substance released from utensils, containers and packaging (UCP) for the purpose of working on the foods, the substance shall be listed in the PL as the substance satisfies the standards of food additive. The amount of the substance is not specified in the PL; however, it shall satisfy the use limit as a food additive when having an effect on food.  Even if a substance listed on the PL for UCP has the same name as a food additive, unless it has the remarks to satisfy the food additive standards, it may not be used as the substance released from UCP with the purpose of having an effect on food.

Example

Food additive A (XX-ic ester) Chemical substance A (XX-ic ester) May be used with the purpose of having an May not be used with the effect on food (Shall satisfy the food additive purpose of having an effect on standards) food Food side Food side

External side External side

Description in the public notice (draft) ●Additives, coating agents, etc. Use restriction by group Substance name Remarks 1 2 3 4 5 6 7

1 XX-ic ester (Food additive) * * * * * * * Shall satisfy the standards of food additive

2 XX-ic ester 1.0 1.0 - - 1.5 1.0 -

37 Specifications and Standards in the PL System (Existing Substances)

 The MHLW is collecting information of the substances that to be specified in the Public Notice while ensuring the consistency of this system with the international standards. At present, more than 2,500 substances are planned to be listed.

Specifications for these substances is need to be established through deliberation of the Committee for UCP of the Food Sanitation Council based on the evaluation results of effects of food on human health by the Food Safety Commission of Japan (FSCJ) pursuant to the Food Safety Basic Act. The FSCJ has been considering evaluation of the substances currently used in UCP that are sold, manufactured, imported and used for business in Japan (Existing substances) based on information available, including use of migration simulation software. However, even with this evaluation method, it seems to take considerable time to complete evaluation for the specifications.

 Existing substances are substances that are already used in UCP, and certain levels of safety information are confirmed prior to their usage to ensure compliance with Article 16 (Prohibition of sale, etc. of toxic or harmful apparatus (utensils) or containers and packaging) of the Food Sanitation Act. Additionally, if the use of substances that have been used in UCP for a long time is prohibited, confusion of manufacturing and sales of food etc. and consequently the stable supply of food are expected.

Therefore, it is necessary to identify all substances that are already being used in UCP and gradually proceed to evaluation of health effects of food after specifying them as the substances specified pursuant to Article 18 (1). To introduce this system smoothly considering the time required for the procedure including the evaluation, it shall be conducted as follows for some substances: improve procedure to establish the Public Notice assuming that the evaluation will be conducted afterwards because these substances are applicable to “Where there is no time to conduct an Assessment of the Effect of Food on Health in advance in cases where the measure is urgently necessary to prevent or restrain an adverse effect on human health” as prescribed in Article 11(1)-3 of the Food Safety Basic Act. 38 Risk Assessment of Existing Substances (Additives)

Source: documents of the 49th FSCJ expert committee on UCP Existing substances Substances Substances unique to Japan whose safety was already evaluated in overseas Utilize business MHLW operators’ data including results Review by experts of migrating test and toxicity Estimation of migration using studies. ≤ 0.05 mg/kg in food (dietary migration simulation software concentration)

＞ 0.05 mg/kg in food Estimation of genotoxicity using (dietary concentration) Careful QSAR models Gather toxicological data such as （ examination including judgment by experts genotoxicity (including use of of the data taken into account available QSAR models) and repeated information on genotoxicity) doze toxicity

Food Safety Commission of Japan (FSCJ) Risk assessment based Risk assessment based on the genotoxicity and the on the data toxicological data 39 Risk Assessment of Existing Materials (Base Polymers)

Source: documents of the 49th FSCJ expert committee on UCP Existing materials: impurities such as monomer and oligomer

Utilize results of migration test from business operators

MHLW Review by experts ≤ 0.05 mg/kg in food (dietary ＞ 0.05 mg/kg in food (dietary concentration) concentration)

Estimation of genotoxicity using QSAR models Gather toxicological data such as （including judgment by experts taken into genotoxicity (including use of QSAR account available information on genotoxicity) models) and repeated doze toxicity

Food Safety Commission of Japan (FSCJ)

Risk assessment based on the genotoxicity and the toxicological data

40 Schedule for Establishment of the PL for the Existing Materials

• List substances using the information from business operators and associations • Preparation of the draft PL

May-June 2019 The draft PL / Committee for UCP established under the Pharmaceutical Affairs and Food Sanitation Council

Summer 2019 Update of the draft PL / Public comment / WTO notification

Ask the Food Safety Commission • List substances to be added in the PL List August 2019 for risk assessment • Final work of the drat PL

As necessary The draft PL / Committee for UCP established under the Pharmaceutical Affairs and Food Sanitation Council

December 2019 Public notice of the PL

June 2020* Start of the PL system : enforcement of the amended Food Sanitation Act *within two years from the date of promulgation of the amended Act 41 Outline of Proposed Amendment to the Standards and Regulations of Foods, Food Additives, etc. (Ministry of Health and Welfare Notification No.370)

• Under the provisions of Article 18 (3), the raw materials for synthetic resins shall be those listed in Appended Table 1. . • Substances used for coloring shall be colorants specified or colorants processed so that they will not be eluted or seeped out into food. • Base polymers listed in the list of polymers in Table 1 (2) of Appended Table 1 shall be produced by polymerizing or cross-linking prepolymers on appropriate base materials. • More than 98 wt% of the components of a base polymer shall be constituted with the polymers in Table 1 (1) or (2) of Appended Table 1, and the remaining components shall be copolymers of monomers listed in Table 1 (3) of in Appended Table 1.

Appended Table 1 Table 1 Base polymers (1) Base polymers (Plastics) (2) Base polymers (Coatings etc.) (3) Minor monomers can be used for polymerization of base polymers

Table 2 Additives etc. (1) Additives, coating agents, etc.

42 Website for the UCP Positive List system

MHLW website: “About the Positive List System for Food Utensils, Containers and Packaging” https://www.mhlw.go.jp/stf/newpage_05148.html

Lists of substances *The substances in these lists are those prepared by the MHLW based on the information currently available, and are subject to additions and modifications.

・物質リスト整理表 1(Base polymers ) (2019年６月21日時点) ［xlsx形式：199KB］・物質リスト整理表2(Additives, coating agents, etc.) (2019年６月28日時点) ［xlsx 形式：212KB］

・物質リスト整理表(参考リスト) (2019年６月 13日時点) ［xlsx形式：60KB］

43 Reference

 MHLW website (utensils, containers and packaging: UCP) http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/kigu/index.html  Committee of Utensils, Containers and Packaging of the Food Sanitation Council established under the Pharmaceutical Affairs and Food Sanitation Council  Committee for Reviewing the Regulations on Food Utensils, Containers and Packaging  Report and Interim Report by the Committee for Reviewing the Regulation of Food Utensils, Containers and Packaging (Japanese and English)  Guideline for safety assurance in the manufacture, etc. of food utensils, containers and packaging (Japanese and English) http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500- Shokuhinanzenbu/0000188507.pdf  About the amendment of the Food Sanitation Act http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000197196.html